Good laboratory practice

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Good Laboratory Practice (GLP) ( English Good Laboratory Practice ) is a formal framework for the implementation of safety tests on chemicals, pharmaceuticals, pesticides, food additives and explosives. GLP is required by law in many countries.

The scope of application according to GLP regulation is the "non-clinical [n] experimental [n] tests of substances or preparations, the results of which allow an assessment of their possible dangers for humans and the environment in an approval, permit, registration, notification or notification process are to be carried out in compliance with the principles of good laboratory practice according to Appendix 1 of the Act. "

The GLP defines the organizational process and the conditions under which laboratory tests are planned, carried out and monitored. They also deal with the recording and reporting of the test. Studies carried out according to GLP are usually assessed with the Klimisch Score 1.

New experiments for data collection within the framework of the EU chemicals regulation REACH must be carried out in accordance with GLP (Good Laboratory Practice). REACH stands for Registration, Evaluation, Authorization and Restriction of Chemicals , i.e. for the registration, evaluation, authorization and restriction of chemicals.

The OECD is involved in the international organization and as an orientation aid for the various countries for the GLP. The German Federal Agency for Good Laboratory Practice (GLP Federal Agency) is based at the Federal Institute for Risk Assessment (BfR) .

GLP is legally anchored in EC directives and in Germany in the Chemicals Act (ChemG). The "Principles of Good Laboratory Practice (GLP)" are stored in Appendix 1 of the ChemG.

Historical development

When a pharmaceutical product was registered in the USA in the 1970s, the competent authority, the Food and Drug Administration (FDA), found that the tests carried out and the test data presented did not match. This sparked a public discussion that laboratories should not act in an economic interest. The FDA developed a set of rules which was called “Good Laboratory Practice (GLP)”. However, this was still difficult to apply to other types of laboratories, such as B. analytical test laboratories transferred.

The member states of the EC also adopted the GLP. In Germany, this took place in 1990 through the rewriting of the ChemG. DIN EN ISO / IEC 17025 was later adopted into the German set of standards, which is supplemented by DIN EN ISO 15189 for medical laboratories. The BfR's last GLP publication was published on January 1, 2018 and dealt with the "implementation of GLP inspections in Germany".

The GLP has also been introduced in the other most important industrialized countries, which supplements the normal quality management systems and is subject to state inspection. 

aims

  • Traceability of examinations through complete documentation
  • Establishing responsibilities
  • Clear organizational rules
  • Generation of data of appropriate quality for the evaluation of a product
  • International mutual recognition of data
  • Avoidance of multiple examinations

Advantages and disadvantages

advantages disadvantage
Greater efficiency Costs (initially approx. 20% higher costs during a period, later only 5%)
Better specialization
Better competitiveness
Better reputation among customers and the general public

Conclusion: The higher costs are offset by higher sales and thus profit and profitability.

Management and laboratory requirements

In principle, the same quality development and quality management procedures apply to laboratories as to any other company.

  • Establishment and documentation of a company vision and a company goal
  • Every employee should have the opportunity to participate in quality development
  • The quality goals should focus on the areas that are important to the customer
  • Quality goals should gradually be formulated within a realistic scope
  • Customers, managers and employees should be involved in determining the current quality status

Quality management especially for laboratories is described in more detail below.

It is important to have a good organization so that each employee, including the laboratory manager, has a precise definition of his responsibilities, authorities and tasks. The classic quality management tools can be used for this (e.g. organizational chart). In addition, an employee should be assigned as a quality manager. He should be "independent of other tasks and responsibilities" and be in contact with the upper management levels. He is now responsible for the introduction of a quality management system and, in the future, for continuous quality improvement.

In laboratories, one of the first steps in the introduction of a quality management system is to record all basic work steps and their framework conditions (programs, safety instructions, etc.). In the further course, the constant updating and further development also applies here.

A system has to be developed with the help of which constant quality control can take place and quality gaps can be quickly identified and their causes eliminated. The following questions are helpful for this:

  • Do the written down basic work steps correspond to daily practice?
  • What do the management levels report?
  • Was there an external assessment? If so, what does this mean?
  • Are preventive measures necessary at weak points?
  • How do customers rate the quality of services and products? What causes make up the majority of the complaints?
  • Have new regulations introduced on a trial basis proven themselves?
  • What is the training level of the staff?

The next management review should now determine whether the measures implemented were effective or not.

The creation of documents in the laboratory must be standardized, through which a clear identification of the author (s) must be possible. Here, too, it must be determined who has the authority to change, create and delete documents. Subsequent change options must be excluded or clearly traceable. Great importance should be attached to data protection as much as possible.

Does a laboratory issue e.g. B. Capacity shortage further, the consent of the customer must be obtained and it must be ensured that the laboratory works according to the standards prescribed in Germany, but better still has an accreditation.

It must be checked that chemicals, equipment and other consumables meet the requirements. These tests must be recorded. Furthermore, the area of ​​responsibility must be regulated. In addition, all suppliers and service providers must be regularly assessed and the results entered in a list.

When dealing with customers, confidentiality towards other customers must be maintained. Communication with the customer must also be maintained. When dealing with complaints, the laboratory must establish rules and procedures for dealing with them and keep records of them.

Procedures for dealing with faulty test work must be described in order to meet the requirements. Corrective measures must then be initiated, the customer must be informed and work can only be continued once the error has been rectified. Corrective measures must begin with investigating the cause. Preventive measures for this must also be determined.

Internal audits must be carried out on a regular basis according to a defined plan. These must include all areas of quality management and trained and qualified employees who are as independent as possible from the audited area must be used as auditors. The results must also be recorded.

GLP monitoring bodies in Germany

In addition to the BfR, quality assurance of laboratories in Germany is the responsibility of the individual federal states.

  • Baden-Württemberg: State Institute for the Environment, Measurements and Nature Conservation
  • Bavaria: Bavarian State Office for Health and Food Safety, Central Quality Management; Bavarian State Ministry for Labor and Social Affairs, Family and Women
  • Berlin: State Office for Occupational Safety, State Protection and Technical Safety
  • Brandenburg: Ministry for the Environment, Health and Consumer Protection
  • Bremen: Senator for Labor, Women, Health, Youth and Social Affairs
  • Hamburg: Authority for Social Affairs, Family, Health and Consumer Protection; Office for Occupational Safety and Health, Department of Workplace Assessments
  • Hessen: Hessian Ministry for the Environment, Energy, Agriculture and Consumer Protection; Regional council of Giessen
  • Mecklenburg-Western Pomerania: Ministry of Social Affairs and Health
  • Lower Saxony: State Trade Inspectorate Hildesheim central support point for air pollution control, noise and hazardous substances
  • North Rhine-Westphalia: Ministry of Labor, Health and Social Affairs of the State of North Rhine-Westphalia
  • Rhineland-Palatinate: Ministry for the Environment, Forests and Consumer Protection; State Office for the Environment, Water Management and Trade Inspection
  • Saarland: Ministry for the Environment, Energy and Transport
  • Saxony: Saxon State Ministry for Environment and Agriculture
  • Saxony-Anhalt: Ministry of Agriculture and Environment of the State of Saxony-Anhalt
  • Schleswig-Holstein: Ministry for Agriculture, Environment and Rural Areas
  • Thuringia: Thuringian State Administration Office

In addition, the German Medical Association regularly deals with the quality assurance of medical laboratory examinations and updates the relevant guidelines.

See also

Web links

Itemized list

  1. a b c d Maria-Lucia Oliveira, Elvira Möller: Laboratory manager - management and organization, safety and environment, quality assurance . WEKA specialist publisher for technical executives GmbH, Augsburg 1996, chap. 10 .
  2. UK regulations on GLP. Retrieved July 13, 2018 .
  3. a b c d e Tilo Pfeifer, Robert Schmitt: Masing manual quality management . 6th edition. Carl Hanser Verlag Munich Vienna, Munich 2014, p. 983-1005 .
  4. Different definitions of GLP related terms. Retrieved July 13, 2018 .
  5. G. Law (Ed.): Chemicals Act - ChemG . 2017.
  6. Federal Institute for Risk Assessment. (No longer available online.) Formerly in the original ; accessed on June 30, 2018 .  ( Page no longer available , search in web archivesInfo: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice.@1@ 2Template: Toter Link / www.bfr.bund.de  
  7. ^ PA Carson, NJ Dent: Good Laboratory and Clinical Practices - Techniques for the Quality Assurance Professional . Heinemann Newnes, Oxford 1990.
  8. Karin Letter: 30 minutes of quality management . GABAL Verlag GmbH, Offenbach 2012.
  9. Norbert Hochheimer: The small QM lexicon . 2nd Edition. Wiley-VCH Verlag & Co. KGaA, Weinheim 2011, p. 100 f .
  10. Deutsches Ärzteblatt. Retrieved June 30, 2018 .